CN1704060A - Compound sodium houttuyfonate - Google Patents
Compound sodium houttuyfonate Download PDFInfo
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- CN1704060A CN1704060A CN 200410027308 CN200410027308A CN1704060A CN 1704060 A CN1704060 A CN 1704060A CN 200410027308 CN200410027308 CN 200410027308 CN 200410027308 A CN200410027308 A CN 200410027308A CN 1704060 A CN1704060 A CN 1704060A
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Abstract
The invention provides a compound preparation which comprises Ganciclovir and cordate houttuynia, the dosage type of the preparation can be oral preparation, injection, externally used preparation, the compound preparation can be used clinically for treating diseases initiated by various virus infections, also for treating inflammation and enhancing immunological function, the compound preparation contains therapeutic active dosage of various reactive constituents, preferably, the weight ratio range of the medicinal salts of Ganciclovir and the medicinal salts of cordate houttuynia is 1:20-20:1, preferably 1:5-5:1.
Description
The multiple disease that is caused by viral infection is the harm humans health and lives seriously, according to incompletely statistics, about 60% popular infectious disease causes by viral infection, wherein sickness rate height, the various diseases that is mainly viral hepatitis, acquired immune deficiency syndrome (AIDS) and is caused by herpesvirus that harm is big.Be used for the treatment of clinically at present medicine for treating viral infections mainly contain foscarnet sodium, acyclovir, more former times network Wei etc.The clinical research result shows, compares with foscarnet sodium, acyclovir, and ganciclovir has advantages such as curative effect height, drug resistance are good, antiviral spectrum width.
Ganciclovir (Ganciclovir, ganciclovir sodium Ganciclovir Sodium, 9-(1,3-dihydroxy-2-third oxygen methyl)-guanine list sodium salt, molecular formula: C
9H
12N
5NaO
4Molecular weight: 277.22), be the nucleolus glycoside antiviral agents of developing by U.S. Syntex company, interior activity (the Faulds D and Heal RC that has anti-herpesvirus, cytomegalovirus with in vitro tests proof ganciclovir and have a liking for hepatovirus of body, Drugs, 39:597).First in Britain listing, went on the market in the U.S. in July, 1989 in 1988, is applied to clinical in the listing that gets the Green Light of world's most countries thereafter.Ganciclovir, the existing oral formulations of ganciclovir sodium, ejection preparation, ophthalmic preparation etc.
Ganciclovir has a clear superiority on treatment cytomegalovirus infection disease, but use its antiviral activity not give full play of separately, in clinical practice, often cooperate other drug to use giving full play to its advantage with ganciclovir, such as ganciclovir associating matrine be used for baby's cytomegalovirus hepatitis (contain triumphant, etc., Xinxiang College of Medical Science's journal, 2002,19:224), ganciclovir associating ribavirin therapy pediatric viral encephalitis (is opened the heart, China basic unit medicine, 2002,9:887), ganciclovir associating HDIG treatment cytomegalovirus infection (Wu Xiangyuan, Deng, China's hospital infection magazine, 2002,12:389).
Houttuynine sodium bisulfite (certain herbaceous plants with big flowers acyl acetaldehyde) is the effective ingredient of natural Herba Houttuyniae, Sodium Houttuyfonate (the houttuyninum of present synthetic, lauroyl acetaldehyde sodium sulfite) is houttuynine sodium bisulfite sodium sulfite addition product, have effect (Li Shuan such as antibiotic, diuresis, antitussive, adjusting immunity, Deng, Shenyang Pharmaceutical University's journal, 1997,14:144; Shao Lan, etc., Chinese Pharmacological circular, 2001,17:51; Shenyang Pharmaceutical University's journal, 2000,17:133; Wang Dayong, etc., Shenyang Pharmaceutical University's journal, 2003,20:210).Sodium Houttuyfonate has oral and ejection preparation now.
We discover: ganciclovir cooperates Sodium Houttuyfonate to use the anti-virus ability that can effectively strengthen ganciclovir, and we have developed ganciclovir Sodium Houttuyfonate compound preparation for this reason.
● summary of the invention
Content of the present invention is to propose a kind of compound preparation, and this compound preparation is made up of ganciclovir and houttuynine sodium bisulfite, and dosage form can be oral formulations, ejection preparation, external preparation.
Therefore, the present invention relates to contain the active component ganciclovir, randomly with its a kind of pharmaceutical acceptable salt, as ganciclovir sodium, or its prodrug valganciclovir (valganciclovir), and houttuynine sodium bisulfite is randomly with its a kind of pharmaceutical acceptable salt, as Sodium Houttuyfonate as active component, with the pharmaceutical composition of one or more officinal salts associating.
And, react the officinal salt that obtains ganciclovir with known method by ganciclovir and corresponding acid, alkali.With, react the officinal salt that obtains houttuynine sodium bisulfite with known method by houttuynine sodium bisulfite and corresponding acid, alkali.
Said composition more particularly is suitable for the disease that various viral infections cause, and can also be used for inflammation treatment, raise immunity etc.
The present composition contains the various active component for the treatment of effective dose.Therefore, each consumption ratio of ganciclovir and houttuynine sodium bisulfite correspondingly changes.Preferably, the weight ratio scope of its officinal salt of ganciclovir and houttuynine sodium bisulfite officinal salt is 1: 20-20: 1, preferred 1: 5-5: 1.
The administration of present composition preferred oral, drug administration by injection, ophthalmic drug delivery, vagina administration, percutaneous drug delivery and rectally.
When oral administration, the dosage form of the present composition can be gelatine capsule, plant capsule, granule, dispersible tablet, effervescent tablet, coated tablet, medicine bag, coated tablet, lozenge, suppository, powder, oral liquid, drinks the slow release formulation of bottle or solution, microgranule or above-mentioned various dosage forms, disperse dosage form.
When drug administration by injection, the present composition is injection solution, dry powder or the lyophilized powder and the form of suspension that are packaged in phial, vial or bottle that is used for venoclysis at a slow speed or intramuscular injection.
Active substance and all kinds excipient or carrier such as filler, disintegrate (or broken) agent, binding agent, dyestuff, correctives or the like are mixed, then mixture is shaped, be prepared into oral administered dosage form thus.
Dyestuff can be medicinal any dyestuff.Correctives comprises the agent of various screen flavor, fat material (comprising lecithin, surfactant), hydrophilic medicament embedding medium material (as the agent of polyacrylic resin class medicinal coating film, modified starch series carbohydrate, cyclodextrin glucose oligomer or the like) and ion exchange resin, protein, zeolite, tannic acid, citric acid, the various organic acid of tartaric acid and other pharmaceutic adjuvant, and cocoa powder, Herba Menthae, Borneolum Syntheticum, sweeting agent and cedductor powder.
The example of binding agent is polyvinylpyrrolidone, hydroxypropyl emthylcellulose, hydroxyethyl-cellulose, ethyl cellulose, methylcellulose, carboxymethyl cellulose, alginic acid, carbomer (carbomer), dextrin, starch, sodium alginate, polymethacrylates, maltodextrin, liquid glucose, aluminium silicate marquis and guar gum.
The example of disintegrating agent is alginic acid, carboxymethyl cellulose, colloidal silica, cross-linking sodium carboxymethyl cellulose, crospovidone, guar gum, aluminium-magnesium silicate, methylcellulose, microcrystalline Cellulose, cellulose powder, pregelatinised starch, sodium alginate or sodium starch glycolate.
Filler is cellulose, lactose, calcium hydrogen phosphate and microcrystalline Cellulose.
Use usual method, under the situation that one or more lubricants exist, the granule compacting can be obtained tablet.Suitable lubricant is calcium stearate, glycerol monostearate, rice-pudding paulownia acyl tristerin, hydrogenant Oleum Ricini, hydrogenant vegetable oil, light mineral oil, magnesium stearate, Polyethylene Glycol, sodium benzoate, sodium lauryl sulphate, Fumaric acid octadecyl sodium, stearic acid, Pulvis Talci and zinc stearate.
Can use solution or suspension such as the hydroxypropyl emthylcellulose or the ethyl cellulose of polymer then, these tablets are carried out coating.
As use wet-granulation process, and be starting material with the mixture of active component and one or more excipient such as binding agent, disintegrator (or disintegrating agent) and filler, the used granule of preparation tabletting.
In order to obtain hard capsule, randomly under the situation of lubricant such as magnesium stearate, stearic acid, Pulvis Talci or zinc stearate existence, the mixture of active component and suitable filler (for example lactose) is packed in the empty capsule, and capsule can be gelatine capsule, plant capsule.
Active component is dissolved in the suitable solvent (as Polyethylene Glycol), then packs soft capsule into and make Perle.
Use conventional method, active component is mixed with buffer, stabilizing agent, antiseptic, solubilizing agent, tonicity agent and suspending agent, obtain ejection preparation.According to known technology,, be packaged into the form of intravenous injection, intramuscular injection then subsequently with the sterilization of these blending constituents.
Use conventional method, active component is mixed with buffer, stabilizing agent, antiseptic, solubilizing agent, tonicity agent and suspending agent, obtain ophthalmic preparation.According to known technology, with the sterilization of these blending constituents, pack then subsequently.
Use conventional method, active component is mixed with buffer, stabilizing agent, antiseptic, solubilizing agent, tonicity agent and suspending agent, obtain the vagina administration preparation.According to known technology, with the sterilization of these blending constituents, pack then subsequently.
Use conventional method, active component is mixed with buffer, stabilizing agent, antiseptic, solubilizing agent, tonicity agent and suspending agent, obtain rectal formulation.According to known technology, with the sterilization of these blending constituents, pack then subsequently.
Use conventional method, active component is mixed with buffer, stabilizing agent, antiseptic, solubilizing agent, tonicity agent and suspending agent, obtain external preparation.According to known technology, subsequently with the sterilization of these blending constituents, pack external preparation then, the form of external preparation comprises dosage forms such as ointment, external-use gel, spray, patch, plaster, suppository, absorbent gauze, handwashing liquid, the emulsifiable paste of washing one's hands, spray, facial film, disinfectant
Buffer can use the buffer based on organic phosphate.The example of suspending agent comprises methylcellulose, hydroxyethyl-cellulose, arabic gum and sodium carboxymethyl cellulose.The example of solubilizing agent comprises with polyoxyethylene, Tween 80, relation by marriage amide or the solidified Oleum Ricini of Macrogol.Stabilizing agent can be inferior coloured glaze acid sodium and sodium pyrosulfite etc.Antiseptic can be to an oxybenzene sodium formate, ascorbic acid, cresol and chlorocresol.
In order to prepare oral administration solution or suspension, active component is dissolved in the appropriate carrier with dispersant, wetting agent, suspending agent (as polyvinylpyrrolidone), antiseptic (as methyl parahydroxybenzoate or propyl p-hydroxybenzoate), correctives or dyestuff.
In order to prepare microcapsule, any other additive types associating of active component and suitable diluents, suitable stabilizing agent, the material that promotes the active component slow release or formation SMIS uses suitable polymer (for example resin) with the core coating then.Then, the microcapsule that obtains is randomly made prestige optimal dose unit.
Purpose of the present invention also has, randomly with the more former times network Wei and houttuynine sodium bisulfite officinal salt associating of its a kind of pharmaceutical acceptable salt, and the application in the medicine of preparation treatment viral infection disease.
According to the present invention, term " medication combined " or refer to pharmaceutical composition defined above, wherein two kinds of active component are the solvents in the same compositions, perhaps refer to contain the medicine box of two independent composition components, contain in first compositions former times more the network Wei or the active component of arbitrary forms such as its precursor or metabolite or its officinal salt as unique active component, contain the active component of houttuynine sodium bisulfite or arbitrary forms such as its precursor or metabolite or its officinal salt in second compositions as unique active component., carry out separately when being kit form when medication combined,, carry out simultaneously for therapeutic alliance although constitute the administration of two kinds of compositionss of medicine box.
According to a preferred embodiment of the invention, more former times the network Wei or the consumption of its salt and the part by weight of houttuynine sodium bisulfite be 1: 20-20: 1, preferred 1: 5-5: 1.
When former times more the network Wei and houttuynine sodium bisulfite or its salt mix the back in same unit dose the time, unit dose preferably contains the more former times network Wei of 10-10000mg.Wherein the unit dose of oral formulations still select contain 50-1000mg more former times the network Wei, the unit dose of ejection preparation preferably contain 10-500mg more former times the network Wei, the unit dose of ophthalmic preparation and external preparation preferably contain 100-10000mg more former times the network Wei.The dosage of preparation depends on mode of administration, treatment indication and patient's age and body constitution body weight naturally.
The application of the present composition is described and the advantage of the purposes of asking for protection with reference to the following examples.Use external Virus culture method prove more former times the network Wei and the houttuynine sodium bisulfite compound recipe have stronger antiviral activity than independent more former times network Wei, houttuynine sodium bisulfite.Adopt in the body mouse model prove more former times the network Wei and houttuynine sodium bisulfite have synergism.
Example one, the external anti-hepatitis B activity of former times network Wei Sodium Houttuyfonate compound recipe more
Adopt the Hep G of HBV DNA transfection
22.2.15 cell strain, the normal cell cultural method, by the grouping of following administering mode: blank group (not containing any medicine in the standard cell lines culture fluid), positive controls (in the standard cell lines culture fluid and contain 20mg/ml more former times the network Wei), test group A (contain in the standard cell lines culture fluid 20mg/ml more former times network Wei+10mg/ml Sodium Houttuyfonate), experiment group B (contain in the standard cell lines culture fluid 20mg/ml more former times network Wei+20mg/ml Sodium Houttuyfonate), test group C (contain in the standard cell lines culture fluid 20mg/ml more former times network Wei+40mg/ml Sodium Houttuyfonate).Press as above administering mode, cell culture condition is given down and 10 days continuously, does following check behind collecting cell supernatant and the cell specimen respectively: 1, HBsAg quantitative analysis, adopt the detection of ELISA test kit; 2, HBV DNA quantitative check is used branched chain (bDNA) quantitative analysis test kit and is detected.
Result of the test is as follows:
1, the inhibitory action of HBsAg in the pair cell culture fluid:
1], in the blank group without any medicine, HbsAg was 2.68 μ g/ml along with the prolongation steady and stabilized growth of incubation time by 8 days in the cell conditioned medium liquid.2], HbsAg second day after the administration in the cell conditioned medium liquid in the positive controls (contain in the cell culture fluid 20mg/ml more former times network Wei), along with the continual and steady minimizing of the prolongation of incubation time, relatively stable a level after the 8th day, in the time of its 8th day in the cell conditioned medium liquid HbsAg be 1.43 μ g/ml.3], HbsAg second day after the administration in the cell conditioned medium liquid among the test group A (contain in the cell culture fluid 20mg/ml more former times network Wei+10mg/ml Sodium Houttuyfonate), along with the continual and steady minimizing of the prolongation of incubation time, relatively stable a level after the 8th day, in the time of its 8th day in the cell conditioned medium liquid HbsAg be 1.28 μ g/ml.4], HbsAg second day after the administration in the cell conditioned medium liquid in the experiment group B (contain in the cell culture fluid 20mg/ml more former times network Wei+20mg/ml Sodium Houttuyfonate), along with the continual and steady minimizing of the prolongation of incubation time, in the time of its 8th day in the cell conditioned medium liquid HbsAg be 1.12 μ g/ml.5], HbsAg second day after the administration in the cell conditioned medium liquid among the test group C (contain in the cell culture fluid 20mg/ml more former times network Wei+40mg/ml Sodium Houttuyfonate), along with the continual and steady minimizing of the prolongation of incubation time, in the time of its 8th day in the cell conditioned medium liquid HbsAg be 1.07 μ g/ml.
2, the inhibitory action of the outer HBV DNA of pair cell
1], in the blank group without any medicine, HBV DNA was 782.5 μ g/ml along with the prolongation of incubation time is steady and stabilized growth by 8 days in the cell conditioned medium liquid.2], HBV DNA second day after the administration in the cell conditioned medium liquid in the positive controls (contain in the cell culture fluid 20mg/ml more former times network Wei), along with the continual and steady minimizing of the prolongation of incubation time, relatively stable a level after the 8th day, in the time of its 8th day in the cell conditioned medium liquid HBV DNA be 436.2 μ g/ml.3], HBV DNA second day after the administration in the cell conditioned medium liquid among the test group A (contain in the cell culture fluid 20mg/ml more former times network Wei+10mg/ml Sodium Houttuyfonate), along with the continual and steady minimizing of the prolongation of incubation time, relatively stable a level after the 8th day, in the time of its 8th day in the cell conditioned medium liquid HBV DNA be 396.4 μ g/ml.4], HBV DNA second day after the administration in the cell conditioned medium liquid in the experiment group B (contain in the cell culture fluid 20mg/ml more former times network Wei+20mg/ml Sodium Houttuyfonate), along with the continual and steady minimizing of the prolongation of incubation time, in the time of its 8th day in the cell conditioned medium liquid HBV DNA be 377.8 μ g/ml.5], HBVDNA second day after the administration in the cell conditioned medium liquid among the test group C (contain in the cell culture fluid 20mg/ml more former times network Wei+40mg/ml Sodium Houttuyfonate), along with the continual and steady minimizing of the prolongation of incubation time, in the time of its 8th day in the cell conditioned medium liquid HBV DNA be 342.9 μ g/ml.
Example two, more former times network Wei Sodium Houttuyfonate compound recipe interior resisting virus activity
Virus inoculation is set up the cytomegalovirus infection animal model after adopting BALB/c mouse injection methyl prednisone.Divide into groups by following administering mode: blank group (uninfecting virus does not have any medicine yet), model control group (standard virus infection model group, do not give any medicine), test group A (standard virus infection model group, and give 60mg/kg/d more former times the network Wei), experiment group B (standard virus infection model group, and give the 60mg/kg/d Sodium Houttuyfonate), test group C (standard virus infection model group, and give 60mg/kg/d more former times network Wei+30mg/kg/d Sodium Houttuyfonate).Press as above administering mode, every group of 10 mices in viral infection administration after 2 days, continuous 14 days, write down the mice body weight every day, observe its chaeta, appetite, activity change and record.Finish and mice was all put to death in the 14th day of test, eye socket is got blood, adopts the AU100 automatic biochemistry analyzer to measure the ALT biochemical indicator.
Result of the test is as follows: 1], the model control group mice body weight occurs and do not increase, performances such as hair is lax, growth retardation, appetite is poor, activity is few.It is good that test group A, B, C respectively organize the mice ordinary circumstance, do not find above-mentioned abnormal conditions.2], each group is measured blood ALT result such as following table.The result show former times more the network Wei and the independent use of Sodium Houttuyfonate can obviously reduce the ALT that causes behind the viral infection and raise, it is more obvious that both share the back effect.
Table: ganciclovir and houttuynine sodium bisulfite are to the protective effect of mice
| Grouping | Dosage | ??ALT(/U/L) |
| Blank group | ??37.9±14.1 | |
| Model group | ??100.5±36.8 | |
| Test group A | 60mg/kg/d more former times the network Wei | ??68.2±17.6 |
| Experiment group B | The 60mg/kg/d Sodium Houttuyfonate | ??85.4±22.8 |
| Test group C | 60mg/kg/d more former times network Wei+30mg/kg/d Sodium Houttuyfonate | ??54.9±26.4 |
Claims (6)
1, pharmaceutical composition contains the more former times network Wei as active component, randomly with its a kind of pharmaceutical acceptable salt and houttuynine sodium bisulfite randomly with its a kind of pharmaceutical acceptable salt, with one or more pharmaceutically useful excipient.
2,, be used to prevent and treat the disease that various viral infections cause, and be used for inflammation treatment, raise immunity etc. according to the described pharmaceutical composition of claim 1.
3, according to each described pharmaceutical composition in the claim 1,2, it is characterized in that former times more the network Wei or its can be medicinal salt, the weight ratio of salt that can be medicinal with houttuynine sodium bisulfite or its is 1: 20-20: 1, preferred 1: 5-5: 1.
4, according to the described pharmaceutical composition of aforementioned each claim, it is characterized in that more former times the network Wei and houttuynine sodium bisulfite be various forms of officinal salts.
5,, be suitable for oral administration, drug administration by injection, eye administration, rectally, vagina administration and other forms of topical administration according to the described compositions of aforementioned each claim.
6, according to the described application of aforementioned each claim, it is characterized in that medication combined is to contain the network Wei and the unit dosage form of houttuynine sodium bisulfite or its a kind of pharmaceutical acceptable salt of former times more, its unit dose contain 10-10000mg more former times the network Wei drug regimen.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410027308 CN1704060A (en) | 2004-05-25 | 2004-05-25 | Compound sodium houttuyfonate |
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| CN 200410027308 CN1704060A (en) | 2004-05-25 | 2004-05-25 | Compound sodium houttuyfonate |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2524635C2 (en) * | 2009-09-29 | 2014-07-27 | Этикон, Инк. | Antimicrobial/antibacterial medical devices, coated with traditional preparations of chinese medicine |
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2004
- 2004-05-25 CN CN 200410027308 patent/CN1704060A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2524635C2 (en) * | 2009-09-29 | 2014-07-27 | Этикон, Инк. | Antimicrobial/antibacterial medical devices, coated with traditional preparations of chinese medicine |
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